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Voice-preserving Treatment of Laryngeal Papilloma

Phase 2
18 Years
64 Years
Not Enrolling
Laryngeal Papilloma

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Trial Information

Voice-preserving Treatment of Laryngeal Papilloma

RRP and its surgeries usually involves the vocal cords or other regions of the larynx,
thereby, resulting in a poor voice. Our previous studies have shown the efficacy and safety
of a microvascular targeting technique (MVT) for RRP treatment using the 585 nm PDL. This
technique provides a less traumatic alternative to surgery. However, postoperative
recurrence of lesions still remains a problem because of microvascular regrowth. This study
is a continuation of our effort to develop a new and less traumatic treatment for RRP. In
this study, we will develop a new, combined RRP treatment with PDL and Celebrex. We will
determine if Celebrex, a newly developed inhibitor of COX-2, can provide a long-term
inhibitory effect on RRP through its anti-angiogenic activity and the synergic effect
produced with the laser therapy. The hypothesis is that postoperative administration of
Celebrex will provide a long-term inhibitory effect on microvascular regrowth and on COX-2
enzyme, thereby, preventing RRP from recurring after the PDL therapy. Our specific aim in
this study is to determine the synergic effect between PDL and Celebrex and long-term
efficacy of Celecoxib in preventing postoperative RRP recurrence. We will compare this new
combined strategy with traditional treatments in 30 adult patients. This is the first time
to combined this new laser MVT technique with a COX-2 inhibitor for microvascular targeting
therapy of RRP. This combined strategy, if successful in this proposed study, will provide a
new and ideal "voice-preserving" therapy for RRP that will deliver long-term efficacy in
managing RRP and will be safe and convenient enough for use in out-patient treatment.

Inclusion Criteria:

1. 18 to 64 years of age

2. with laryngeal papillomas requiring surgical treatment

3. willingness to participate in the study

4. a signed informed consent form

Exclusion Criteria:

1. age less than 18 years

2. evidence of mental impairment so that the patient can not understand or sign the
consent form

3. malignant diseases such as laryngeal cancer

4. established coronary heart and artery disorder, cerebrovascular disease, and other
cardiovascular diseases

5. established diabetes, which requires (1) insulin treatment; or (2) more than 2 oral
agents of medication; or (3) to have a baseline HgbA1c >8.0

6. hypertension, with ongoing blood pressure > 150 mg Hg systolic or to require

7. family history with serious cardiovascular events and problems

8. any sign and evidence which in the opinion of cardiovascular physician warrants
exclusion of subject

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Case With Papilloma Recurrence During a 12-month Follow up

Outcome Description:

Criteria for the recurrence: the site scoring >4, plus visible lesion found in >50% of the treated tissue area, after surgery Description: The caculation of the site scoring is based on a called Derkay's scoring system: to indicate how many anatomic site involved, from the 0 (the best)to 13 (the worst),among a total of 13 laryngeal sites such as epiglottis or right true vocal cords.

Outcome Time Frame:

12-month follow up

Safety Issue:


Principal Investigator

Wang Zhi, M.D

Investigator Role:

Principal Investigator

Investigator Affiliation:

Boston Medical Center


United States: Institutional Review Board

Study ID:




Start Date:

May 2005

Completion Date:

July 2009

Related Keywords:

  • Laryngeal Papilloma
  • Papilloma
  • pulsed dye laser
  • Celebrex
  • voice
  • Papilloma



Boston Medical Center Boston, Massachusetts  02118